Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
76
Countries
1
Sites
13
Sepsis-Induced Hypotension
To evaluate the effect of REGN7544 on vasopressor requirements in participants with sepsis-induced hypotension.
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 24 Jun 2025 → 28 Apr 2026
- Decision date (initial)
- 2025-02-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Regeneron Pharmaceuticals
External identifiers
- EU CT number
- 2024-514946-35-00
- ClinicalTrials.gov
- NCT06608901
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Pharmacodynamic, Efficacy, Others, Safety
To evaluate the effect of REGN7544 on vasopressor requirements in participants with sepsis-induced hypotension.
Secondary objectives 6
- To evaluate the safety and tolerability of REGN7544.
- To evaluate the acute effect of REGN7544 on blood pressure.
- To evaluate the effect of REGN7544 on resolution of shock.
- To evaluate the effect of REGN7544 on blood volume regulation.
- To evaluate the PK of REGN7544 following a single IV administration of REGN7544 in participants with sepsis-induced hypotension.
- To assess the immunogenicity of a single IV dose of REGN7544.
Conditions and MedDRA coding
Sepsis-Induced Hypotension
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10021097 | Hypotension | 100000004866 |
| 20.0 | PT | 10040047 | Sepsis | 100000004862 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period.
- Sepsis-induced hypotension that has not responded to intravenous (IV) fluids, receiving 1 or 2 vasopressors and maintaining a Mean Arterial Pressure (MAP) of ≥ 65 mm Hg for at least 2 consecutive hours immediately prior to randomization, as defined in the protocol.
- Other protocol defined inclusion criteria apply.
Exclusion criteria 10
- Unable to obtain informed consent by participant or Legally Authorized Representative (LAR).
- Clinical status requires vasopressor and/or Blood Pressure (BP) management inconsistent with the study protocol
- Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest.
- Ejection fraction <20% in the most recent known echocardiogram.
- Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization.
- History of hospitalization due to heart failure, myocardial infarction, stroke, clinically significant ventricular arrhythmia, transient ischemic attack, or unstable angina within the preceding 3 months.
- Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol.
- Receiving 3 or more vasopressors or exceeding the maximal combined dose as defined in the protocol, during the screening period or at the time of study drug administration.
- Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia.
- Other protocol-defined exclusion criteria apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Cumulative vasopressor dose.
Secondary endpoints 10
- Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 and higher Treatment-Emergent Adverse Events (TEAEs).
- Time-weighted average mean arterial pressure (MAP).
- Change in MAP.
- Proportion of surviving participants free of vasopressor(s).
- Cumulative net fluid balance.
- Cumulative urine output.
- Cumulative fluid intake.
- Concentrations of REGN7544 in serum.
- Incidence of anti-drug antibodies (ADA) to REGN7544.
- Magnitude of ADA to REGN7544.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11526670 · Product
- Active substance
- REGN7544
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- REGENERON PHARMACEUTICALS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Regeneron Pharmaceuticals Inc.
- Sponsor organisation
- Regeneron Pharmaceuticals Inc.
- Address
- 777 Old Saw Mill River Road
- City
- Tarrytown
- Postcode
- 10591-6717
- Country
- United States
Scientific contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Clariness GmbH ORG-100045306
|
Hamburg, Germany | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Icon Laboratory Services Inc. ORG-100037135
|
Farmingdale, United States | Other |
| SanaClis s.r.o. ORG-100033651
|
Ruzinov, Slovakia | Other |
| Sharp Clinical Services (UK) Limited ORG-100011789
|
Tredegar, United Kingdom | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 31 | 13 |
| Rest of world
United States, United Kingdom
|
— | 45 | — |
Investigational sites
Les Hopitaux Universitaires De Strasbourg
Intensive Care Department, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Regional Universitaire De Tours
Intensive Care Department, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Assistance Publique Hopitaux De Paris
Intensive Care Department, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Assistance Publique Hopitaux De Paris
Medical Intensive Care Unit, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Assistance Publique Hopitaux De Paris
Medical Intensive Care Unit, 104 Boulevard Raymond Poincare, 92380, Garches
Centre Hospitalier Departemental Vendee
Intensive Care Department, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Universitaire D Orleans
Medical Intensive Care Unit, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Hopital Nord Franche Comte
Intensive Care Department, 100 Route De Moval, 90400, Trevenans
Centre Hospitalier Universitaire D'Angers
Medical Intensive Care Unit, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Et Universitaire De Limoges
Medical Intensive Care Unit, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Le Mans
Medical-Surgical Intensive Care Department, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier Universitaire Reims
Medical Intensive Care Unit, Rue Du General Koenig, 51092, Reims Cedex
Centre Hospitalier Universitaire De Nantes
Intensive Care Department, 30 Boulevard Jean Monnet, 44000, Nantes
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-06-24 | 2026-04-21 | 2025-06-24 | 2026-01-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-514946-35-00_Redacted | AM2 |
| Recruitment arrangements (for publication) | K1_R7544-SIH-2435_Recruit-ICF process_FP | 1.1 |
| Recruitment arrangements (for publication) | K2_R7544-SIH-2435_Recruitment material_Statement_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R7544-SIH-2435_Recruitment material_Study Brochure_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_R7544-SIH-2435_SIS-ICF_Main_en_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_R7544-SIH-2435_SIS-ICF_Main_fr_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_R7544-SIH-2435_SIS-ICF_PP_FP | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-514946-35-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-514946-35-00 Track changes | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2024-514946-35-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2024-514946-35-00 Track changes | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-28 | France | Acceptable 2025-02-18
|
2025-02-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-16 | France | Acceptable | 2025-06-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-05 | France | Acceptable 2025-10-24
|
2025-10-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-07 | France | Acceptable 2026-02-13
|
2026-02-18 |